Some direct patent infringement “acceptable price” for expediting competition:  U.S. Solicitor General urges Supreme Court to review skinny labeling and generic drug access

Context:

• Brand-name drugs are frequently protected by patents, which sometimes cover the drug itself and/or the particular method of using that drug. In 1984, United States Congress introduced a pathway to expedite competition (Hatch-Waxman), where some but not all approved methods of using a particular drug are patent-protected. Under this, a generic drugmaker may seek approval from the U.S. Food and Drug Administration (FDA) for a non-patented use and sell its generic drug under “skinny” labeling that “carves out” patented uses but otherwise duplicates the brand’s labeling.
• In 2012, the FDA approved a drug developed by Ireland-based pharma company Amarin and sold under the name “Vascepa” (Icosapent Ethyl), which is used to treat patients with two conditions involving excessive levels of triglycerides, a type of fat that circulates in the blood. In 2016, UK-based Hikma submitted an abbreviated new drug application (ANDA) for a generic version of Icosapent Ethyl, amending its application in 2019 to seek the FDA’s approval of a skinny label for its generic product. The ANDA was approved in May 2020. Six months later, Amarin sued Hikma in the United States District Court for the District of Delaware, alleging that Hikma had actively induced others to infringe Amarin’s method-of-use patents (November 30, 2020 complaint). The District of Delaware dismissed its suit in October 2022, but the Federal Circuit reversed that decision last year, concluding that “the totality of the allegations” in Amarin’s complaint “plausibly states a claim for induced infringement” (June 25, 2024 Federal Circuit decision).

What’s new: United States Solicitor General D. John Sauer has filed a petition for a writ of certiorari with the Supreme Court, arguing that the Federal Circuit’s decision threatens the availability of lower-cost generic drugs (December 5, 2025 petition). “So long as generic manufacturers do not encourage infringing uses of their drugs, some measure of direct patent infringement is an acceptable price for expediting generic competition with respect to non-infringing uses,” Mr. Sauer has written in the petition.

Direct impact and wider ramifications: It will be interesting to see whether the Supreme Court takes this case up, and, if so, whether it will agree with the General Solicitor that the Federal Court’s decision could impede competition and harm consumers. Reviewing and confirming the section viii pathway (which allows generics labeled only for non-infringing uses to quickly come to market) could harm pharmaceutical patentees, which have suffered a few blows in U.S. patent infringement cases this year. Earlier this month, for example, the Federal Circuit issued a precedential opinion declaring one of Seattle Genetics’s (Pfizer) breast cancer patents invalid and throwing out a $42M+8% verdict it had won against Daiichi and AstraZeneca (December 3, 2025 ip fray article). Novo Nordisk (August 18, 2025 ip fray article), Novartis (July 25, 2025 ip fray article), and Lindis (July 23, 2025 ip fray article) also suffered huge losses in their respective suits over Wegovy, Entresto, and leukemia drug Blincyto. The latter had a $50 million damages decision thrown out on appeal.